TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	34	34
Material Separation	30	30
Contamination /Decontamination Problem	26	26
Detachment of Device or Device Component	11	11
Microbial Contamination of Device	8	8
Detachment Of Device Component	8	8
Material Fragmentation	7	7
Sparking	7	7
Material Integrity Problem	7	7
Insufficient Information	6	6
Maintenance Does Not Comply To Manufacturers Recommendations	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Fracture	4	4
Crack	4	4
Leak/Splash	4	4
Mechanical Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Flare or Flash	2	2
No Apparent Adverse Event	2	2
Smoking	2	2
Device Damaged by Another Device	2	2
Wire(s), breakage of	2	2
Component Falling	2	2
Contamination	2	2
Calcified	2	2
Peeled/Delaminated	2	2
Failure to Power Up	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1
Retraction Problem	1	1
Bent	1	1
Inflation Problem	1	1
Material Invagination	1	1
Charred	1	1
Material Disintegration	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Flaked	1	1
Fluid/Blood Leak	1	1
Device Issue	1	1
Physical Resistance	1	1
Arcing	1	1
Failure to Cut	1	1
Difficult to Advance	1	1
Device Dislodged or Dislocated	1	1
Electrical Shorting	1	1
Improper or Incorrect Procedure or Method	1	1
Material Perforation	1	1
Misfocusing	1	1
Component Missing	1	1
Mechanics Altered	1	1
Blocked Connection	1	1
Appropriate Term/Code Not Available	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
No Consequences Or Impact To Patient	29	29
Bacterial Infection	23	23
Insufficient Information	22	22
Foreign Body In Patient	21	21
Unspecified Infection	16	16
No Known Impact Or Consequence To Patient	12	12
Device Embedded In Tissue or Plaque	7	7
Patient Problem/Medical Problem	6	6
Unspecified Kidney or Urinary Problem	4	4
No Information	4	4
Urinary Tract Infection	4	4
Burn(s)	2	2
Skin Inflammation/ Irritation	2	2
No Patient Involvement	2	2
Fever	1	1
Hemorrhage/Bleeding	1	1
Bruise/Contusion	1	1
Pain	1	1
Pneumonia	1	1
Tissue Damage	1	1
Urinary Retention	1	1
Abrasion	1	1
Scar Excision	1	1
Unspecified Heart Problem	1	1
Intra-Abdominal Hemorrhage	1	1
Unspecified Hepatic or Biliary Problem	1	1